Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients
Completed · Phase 4 · Has a placebo group
Conditions studied: Pain
In brief
STUDY OBJECTIVES: 1. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in decreasing pain in orthopedic trauma patients with fractures of the extremities, face, pelvis and/or ribs compared to patients not receiving the medication. 2. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in decreasing the use of opioid analgesics among orthopedic trauma patients with fractures of the extremities, face, pelvis, and/or ribs compared to compared to patients not receiving the medication.
Key facts
- Study ID
- NCT02152163
- Run by
- Delray Medical Center
- People needed
- 99
- Starts
- 2012-10-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2021-07-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Trauma patient admitted to Trauma ICU or Trauma Step-Down Units.
- Fracture of ribs, face, extremities and/or pelvis
- Age between 18 and 75 years old
- Adequate IV access
- Able to self report and communicate pain severity
You may not qualify if…
- History of allergy or hypersensitivity to any component of IV Ibuprofen, aspirin (or aspirin related products) NSAIDs, or COX-2 inhibitors
- Any intracranial or spinal cord trauma
- History of clinically significant bleeding disorders including ITP, DIC or platelet dysfunction
- Recent history of intracranial surgery or stroke (within past 30 days)
- History of ulcers, gastritis or previous GI bleeding
- Renal Impairment (Creatinine > 3.0 mg/dL)
- Pregnant or breastfeeding
- Otherwise unsuitable in the opinion of the treating physician at time of randomization.
Where it is running
- Delray Medical Center — Delray Beach, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.